异亚丙基莽草酸原料及其制剂抗栓素片的含量及稳定性研究

Studies on determination of 3,4-O-isopropylidene-shikimic acid by HPLC and its stability in Kangshuansu tablet

目的建立抗栓素片中异亚丙基莽草(ISA)的含量测定方法。方法采用RP-HPLC,Nova-pak-C18柱(3.9mm×150mm,4μm),流动相为乙腈-0.05%磷酸水溶液(15:85);检测波长:220nm;流速:0.8mL·min-1。结果异亚丙基莽草酸在0.1024-4.7268μg线性关系良好,r=0.9999(n=6),平均回收率为103.04%,RSD为1.21%(n=5)。结论本方法灵敏、准确、操作简便,重现性良好。

OBJECTIVE: To establish a HPLC method for determining 3,4-O-isopropylidene- shikimic acid in Kangshuansu tablet. METHODS: A RP-HPLC separation was performed on a Nova pak-C18 column (3.9 mm × 150 mm,4 μm, Waerts, USA). The mobile phase was acetonitrile-0.05% phosphoric acid solution (15:85) at a flow rate of 0.8 mL&middotmin-1, and the detection wavelength was 220 nm. RESULTS: A good linearity for 3,4-O-isopropylidene-shikimic acid was obtained within the range of 0.102 4 ∼ 4.726 8 μg (r = 0.999 9), and the recovery was 103.04% (RSD = 1.21%, n = 5). CONCLUSION: The method is sensitive, accurate and simple, with a good reproducibility.